Events

Dynabeads HLA Class II and Dynabeads HLA Cell Prep II. An in vitro diagnostic medical device (IVD) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Bio-Strategy Pty Ltd 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    RC-2017-RN-00645-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-05-22
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00645-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • 데이터 추가 비고
  • 원인
    The manufacturer has recently identified an impurity (bacterial endotoxins) in the raw material used for the final formulation of the finished product of dynabeads hla class ii and dynabeads hla cell prep ii. their investigation determined that the presence of these endotoxins along with any deviation from the recommended cell isolation temperature in the user manual (e.G. performing some steps or storing product at room temperature) may reduce cell viability and lead to failure of the negative control.
  • 조치
    Bio-Strategy are advising users to discontinue use of the affected material immediately, and to quarantine and place all unused product in a box at ambient temperature ready for collection. Bio-Strategy will arrange for the collection, and will provide replacement product or issue credit..

Device

Dynabeads HLA Class II and Dynabeads HLA Cell Prep II. An in vitro diagnostic medical device (IVD)
  • 모델명 / 제조번호(시리얼번호)
    Dynabeads HLA Class II and Dynabeads HLA Cell Prep II. An in vitro diagnostic medical device (IVD)Dynabeads HLA Class IICatalogue Number: 21003Lot Numbers: 00461955, 00477414, 00480193Catalogue Number: 21004DLot Numbers: 00461951, 00469604, 00477401, 00480209 Dynabeads HLA Cell Prep IICatalogue Number: 21903Lot Number: 00469606, 00477408, 00480204Catalogue Number: 21904Lot Numbers: 00455989, 00461965, 00469615, 00492942
  • Manufacturer
    Bio-Strategy Pty Ltd

Manufacturer

Bio-Strategy Pty Ltd